MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED; PROSTHESIS, ESOPHAGEAL

Catalog Number EVO-FC-18-23-10-E

Device Problem Tip breakage (1638)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

The evolution esophageal catheter broke at the tip where the blue band meets the clear portion of the catheter.This occurred while advancing the catheter in the pt's mouth over a wire cover.Although requested no further details have been received.No adverse effects to the pt have been reported as occurring.As per complaint info received a section of the device did not remain in the pts body.

Manufacturer Narrative

Incident meets the reporting criteria of an fda mdr report based on the reporting precedence established for this product family for 'tip separation'; regardless of pt outcome.To date, the device involved in this complaint has not been received at cook (b)(4).With the info provided a document based investigation was carried out.The customer complaint could be confirmed based on customer testimony.As the device has not been received; therefore the cause of this complaint could not be conclusively determined.Prior to distribution, all evo-fc-18-23-10-r devices are subject to visual inspection and functional checks to ensure device integrity.A review of the mfg records for the evo-fc-18-23-10-e device lot number c955892 revealed no discrepancies that could have contributed to this complaint issue.From the info provided, there were no adverse effects to the pt reported as a result of this occurrence.Complaints of this nature will continue to be monitored for emerging trends.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr. regulatory aff ; 61334440
• MDR Report Key: 4322005
• MDR Text Key: 5248932
• Report Number: 3001845648-2014-00288
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2015
• Device Catalogue Number: EVO-FC-18-23-10-E
• Device Lot Number: C955892
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1